Drugs List

Therapeutic Indications

Uses

Labour - induction of

Unlicensed Uses

Maintenance of patency of ductus arteriosus (before corrective surgery)

Administration

For intravenous infusion.

Contraindications

History of difficult or traumatic childbirth
Parity greater than 5
Previous Caesarean section
Cardiac disorder
Cephalopelvic disproportion
Foetal distress
Foetal malpresentation
Hepatic disorder
History of pelvic inflammatory disease
History of uterine surgery
Placenta praevia
Pulmonary disease
Renal disorder
Uncontrolled pelvic inflammatory disease
Undiagnosed vaginal bleeding during current pregnancy
Uterine hypertonia

Precautions and Warnings

Risk factors for disseminated intravascular coagulation
Alcoholism
Asthma
Cardiovascular disorder
Epileptic disorder
Glaucoma
History of asthma
History of seizures
Hypertension
Raised intra-ocular pressure
Scarred uterus

Treatment to be prescribed under the supervision of a specialist
Contains alcohol
Avoid contact of product with skin
Must be diluted before use; see product information
Monitor uterine contractions and foetal heart rate
Pregnancy: Monitor for disseminated intravascular coagulation postpartum
Discontinue if uterine hyperactivity and/or foetal distress occurs

Before use, evaluate cephalopelvic relationships and do not use in cases of cephalopelvic disproportion.

During use, uterine activity, foetal status and the progression of cervical dilation should be monitored in order to detect possible adverse effects such as hypertonus, sustained uterine contractions or foetal distress. In patients with a history of hypertonic uterine contractility or tetanic uterine contractions, uterine activity and foetal state should be continuously monitored throughout labour. When high-tone uterine contractions are sustained, the possibility of uterine rupture should be considered.

Women aged 35 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of post-partum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labour induction. Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum phase.

Dinoprostone should not be administered by the intramyometrial route as there is a possible association between this route and cardiac arrest in severely ill patients.

Maintain patency of ductus arteriosis in neonate (unlicensed use)
Monitor arterial oxygenation, heart rate, temperature, and blood pressure in arm and leg; facilities for intubation and ventilation must be immediately available.

During infusion of dinoprostone, the newborn requires careful monitoring of heart rate, blood pressure, respiratory rate and core body temperature.

Pregnancy and Lactation

Pregnancy

Dinoprostone infusion is used to induce labour during pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Dinoprostone infusion is excreted in breast milk. This is not expected to be harmful due to the nature in which the product is used.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abruptio placentae
Amniotic fluid embolism
Anaphylactic shock
Asthma
Back pain
Bronchospasm
Cardiac arrest
Diarrhoea
Dizziness
Erythema at injection site
Fever
Flushing
Foetal bradycardia
Foetal distress
Headache
Hypersensitivity reactions
Hypertension
Intravascular coagulation (disseminated)
Irritation (injection site)
Low Apgar score in newborn
Nausea
Neonatal death
Rapid cervical dilation
Shivering
Stillbirth
Uterine hypertonus
Uterine rupture
Vomiting
White blood cell count raised

Presentation

Infusions of dinoprostone.

Drugs List

Therapeutic Indications

Uses

Labour - induction of

Unlicensed Uses

Maintenance of patency of ductus arteriosus (before corrective surgery)

Dosage

Adults

Neonates

Additional Dosage Information

Administration

For intravenous infusion.

Contraindications

History of difficult or traumatic childbirth
Parity greater than 5
Previous Caesarean section
Cardiac disorder
Cephalopelvic disproportion
Foetal distress
Foetal malpresentation
Hepatic disorder
History of pelvic inflammatory disease
History of uterine surgery
Placenta praevia
Pulmonary disease
Renal disorder
Uncontrolled pelvic inflammatory disease
Undiagnosed vaginal bleeding during current pregnancy
Uterine hypertonia

Precautions and Warnings

Risk factors for disseminated intravascular coagulation
Alcoholism
Asthma
Cardiovascular disorder
Epileptic disorder
Glaucoma
History of asthma
History of seizures
Hypertension
Raised intra-ocular pressure
Scarred uterus

Treatment to be prescribed under the supervision of a specialist
Contains alcohol
Avoid contact of product with skin
Must be diluted before use; see product information
Monitor uterine contractions and foetal heart rate
Pregnancy: Monitor for disseminated intravascular coagulation postpartum
Discontinue if uterine hyperactivity and/or foetal distress occurs

Before use, evaluate cephalopelvic relationships and do not use in cases of cephalopelvic disproportion.

During use, uterine activity, foetal status and the progression of cervical dilation should be monitored in order to detect possible adverse effects such as hypertonus, sustained uterine contractions or foetal distress. In patients with a history of hypertonic uterine contractility or tetanic uterine contractions, uterine activity and foetal state should be continuously monitored throughout labour. When high-tone uterine contractions are sustained, the possibility of uterine rupture should be considered.

Women aged 35 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of post-partum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labour induction. Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum phase.

Dinoprostone should not be administered by the intramyometrial route as there is a possible association between this route and cardiac arrest in severely ill patients.

Maintain patency of ductus arteriosis in neonate (unlicensed use)
Monitor arterial oxygenation, heart rate, temperature, and blood pressure in arm and leg; facilities for intubation and ventilation must be immediately available.

During infusion of dinoprostone, the newborn requires careful monitoring of heart rate, blood pressure, respiratory rate and core body temperature.

Pregnancy and Lactation

Pregnancy

Dinoprostone infusion is used to induce labour during pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Dinoprostone infusion is excreted in breast milk. This is not expected to be harmful due to the nature in which the product is used.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abruptio placentae
Amniotic fluid embolism
Anaphylactic shock
Asthma
Back pain
Bronchospasm
Cardiac arrest
Diarrhoea
Dizziness
Erythema at injection site
Fever
Flushing
Foetal bradycardia
Foetal distress
Headache
Hypersensitivity reactions
Hypertension
Intravascular coagulation (disseminated)
Irritation (injection site)
Low Apgar score in newborn
Nausea
Neonatal death
Rapid cervical dilation
Shivering
Stillbirth
Uterine hypertonus
Uterine rupture
Vomiting
White blood cell count raised

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last full review: September 2018

Reference Sources

Summary of Product Characteristics: Prostin E2 sterile solution 1mg/ml. Pharmacia Ltd. Revised January 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 September 2018